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Full-time
bachelor degree
Posted 66d ago
~40 hrs/week
Responsibilities
Lead a multi-skilled maintenance team to ensure the reliability and performance of manufacturing equipment and facility infrastructure in a regulated medical device environment. Drive asset reliability through preventive and predictive maintenance programs while ensuring strict compliance with FDA, GMP, and OSHA standards.
Requirements
Requires a Bachelor's degree in Engineering or a related field with over 7 years of maintenance experience in highly regulated manufacturing and at least 5 years in a leadership role. Expertise in injection molding, automation, and CMMS platforms is essential.
Full job description
Position Summary:
The Maintenance Manager is responsible for the reliability, performance, and continuous improvement of all manufacturing equipment, facilities, utilities, and critical plant systems within a regulated medical device manufacturing environment. This role leads a multi-skilled maintenance team supporting injection molding, high-speed automation, HVAC, electrical, and facility infrastructure systems. The manager drives asset reliability, preventive and predictive maintenance programs, operational excellence initiatives, capital projects, and CMMS optimization while ensuring compliance with safety, quality, FDA, GMP, and OSHA requirements. This position partners closely with Engineering, Operations, Quality, and EHS to maximize uptime, improve OEE, reduce costs, and support business growth.
This role is 100% onsite at our Dublin, OH manufacturing facility.
Essential Duties & Responsibilities:
Leadership & Strategy
Lead, coach, and develop maintenance and facilities personnel to achieve safety, reliability, quality, and productivity objectives.
Develop and execute the site maintenance strategy aligned with TPM, reliability-centered maintenance, and operational excellence principles.
Establish department goals, KPIs, budgets, and performance metrics to drive accountability and continuous improvement.
Reliability & Asset Management
Drive equipment reliability through preventive, predictive, and condition-based maintenance programs.
Utilize CMMS systems to manage work orders, maintenance planning, asset history, and spare parts inventory.
Analyze equipment performance data and implement corrective actions to improve asset uptime and Overall Equipment Effectiveness (OEE).
Lead root cause investigations for equipment failures and recurring downtime events.
Safety, Compliance & Quality
Maintain a safe, compliant, and audit-ready facility through adherence to FDA, GMP, OSHA, and company requirements.
Ensure maintenance activities are executed in accordance with approved procedures, quality standards, and regulatory requirements.
Lead and support EHS investigations, corrective actions, and risk reduction initiatives.
Facilities & Utilities Management
Oversee the maintenance and performance of facility systems including HVAC, boilers, chilled water, compressed air, fire protection, DI water, vacuum systems, and building infrastructure.
Manage contractor and vendor relationships, service agreements, permits, and project execution.
Continuous Improvement & Capital Projects
Identify and lead cost reduction, energy efficiency, sustainability, and reliability improvement projects.
Manage capital projects from concept through implementation, including budgeting, scheduling, validation support, and startup activities.
Collaborate with Engineering and Operations to evaluate and implement new technologies and process improvements.
Knowledge, Skills & Qualifications:
Strong leadership, communication, coaching, and team development skills.
Demonstrated expertise in maintenance management within a regulated manufacturing environment.
Extensive knowledge of injection molding equipment, robotics, automation, packaging systems, and supporting utilities.
Proficiency with CMMS platforms and maintenance planning methodologies.
Strong background in TPM, Lean Manufacturing, Six Sigma, and continuous improvement initiatives.
Experience conducting root cause analysis using structured problem-solving methodologies.
Knowledge of FDA, GMP, ISO, OSHA, and other applicable regulatory requirements.
Ability to manage budgets, capital expenditures, and maintenance-related financial performance.
Proficiency in Microsoft Office Suite and maintenance reporting systems
Education and Experience:
Required
Must be 18 years of age
Bachelor’s degree in engineering, Industrial Technology, Facilities Management, or related field; equivalent experience considered.
7+ years of maintenance experience within medical device manufacturing, pharmaceutical, or highly regulated manufacturing environments.
Minimum 5 years leading maintenance, facilities, or reliability teams.
Demonstrated success managing preventive maintenance programs, capital projects, regulatory compliance, and asset reliability initiatives.
Preferred
Certified Maintenance & Reliability Professional (CMRP).
Lean Six Sigma Green Belt or higher.
Experience supporting ISO 13485 or FDA regulated manufacturing operations
Physical Requirements and Work Environment:
Most activities will occur within a manufacturing clean room environment with some office requirements
Work tasks may be periodically performed outside or on the roof.
Work tasks may take place in a clean room manufacturing environment requiring the use of appropriate gowning and/or PPE.
May need to stand for extended periods of time.
Walk, climb stairs, respond to color or special visual indicators.
Periodically, must be able to lift to 50 lbs. without assistance (equipment, parts etc.)
Typically requires travel less than 10% of the time
ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.
With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.
We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:
Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
Significant US IV solutions manufacturing and supply capabilities.
ICU Medical EEO Statement:
ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [email protected]. We are committed to providing equal access and opportunities for all candidates.
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables.
Since IV therapy is our only business, meeting your IV needs with quality products and consistent supply is our only concern. We are 100% focused on bringing you intuitive, patient-centric IV products and services that provide meaningful clinical differentiation, consistent innovation, and superior value. We design our products to work within your existing workflows to minimize disruption and maximize the time you spend with patients.
Together, we help forge the human and emotional connections that enhance clinical experience and are the essence of outstanding quality of care.
For more than three decades, we have been dedicated to a singular purpose—improving the safety and efficiency of IV therapy. With the acquisition of Hospira Infusion Systems from Pfizer in 2017, we became the only company to focus exclusively on IV therapy across the continuum of care.
Our focus allows us to bring you:
> Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
> The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
> IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
> Significant US IV solutions manufacturing and supply capabilities.
Offices: 951 Calle Amanecer, San Clemente, CA 92673, US · 4455 Atherton Drive, Salt Lake City, Utah 84123, US · Rancho Santa Clara, El Valle De Mandedero, Ensenada, Baja California 22790, MX · 3900 W Howard Ln, Austin, Texas 78728, US · 1 KM West Plaza Real Cariari, La Aurora, Heredia 40104, CR
Critical Carenursingmedical devicespharmacistinfection controlhealthcare informaticspatient safetyhemodynamic monitoringIV TherapyClosed System Transfer Devices
How many Engineering jobs are open in Dublin, OH right now?
There are currently 125 open engineering positions in Dublin, OH listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Dublin, OH?
Companies currently hiring include OCLC, Amazon, ICU Medical, Johnson Controls, Sarnova, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Dublin, OH?
Yes — 33 of the 125 open engineering positions offer remote or hybrid work (7 remote, 26 hybrid).
How do I apply for Engineering jobs in Dublin, OH?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.